Neovascular Age-related Macular Degeneration study: Susvimo PDS Implant vs Ranibizumab
Official title A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
ClinicalTrials.gov ID: NCT06847542
What this study is testing
What is Ranibizumab?
This is an investigational eye medicine being studied to treat neovascular age-related macular degeneration. It is designed to block a protein called VEGF that helps new, leaky blood vessels grow in the eye.
Also referred to as RO4893594.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether the port delivery system with ranibizumab works well and is safe when refilled every 36 weeks.
- Who it's for
- You may be able to join if you have neovascular age‑related macular degeneration and can use a refillable eye device.
- What's involved
- You will receive a small implant that delivers ranibizumab. The implant is refilled at the clinic every 36 weeks. You will have eye exams and answer questions about how you feel.
- Time commitment
- The study lasts 36 weeks, with visits at the start and every 36 weeks for refills and eye checks.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Initial diagnosis of nAMD within 24 months prior to screening
- Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior...
- Demonstrated response to prior anti-VEGF IVT treatment since diagnosis
- Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
- Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
You likely can't join if
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)
- Previous treatment with corticosteroid intravitreal injection
- Previous intraocular device implantation
- History of vitreous hemorrhage
- History of rhegmatogenous retinal detachment
- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
See the full eligibility criteria
- Initial diagnosis of nAMD within 24 months prior to screening
- Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening
- Demonstrated response to prior anti-VEGF IVT treatment since diagnosis
- Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
- Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
- BCVA of 34 letters or better using ETDRS chart at a starting distance of 4 meters at screening and enrollment visits
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)
- Previous treatment with corticosteroid intravitreal injection
- Previous intraocular device implantation
- History of vitreous hemorrhage
- History of rhegmatogenous retinal detachment
- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the ranibizumab injections, study-related procedure preparations (including fluorescein)...
- Prior participation in a clinical trial involving any experimental therapies for nAMD
- Subretinal hemorrhage that involves the center of the fovea
- CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorioretinopathy, or pathologic myopia
- Subfoveal and/or juxtafoveal retinal pigment epithelial tear
- Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results
- Active intraocular inflammation
- Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated or treated within 3 months prior to the enrollment visit
- Aphakia or absence of the posterior capsule
- Uncontrolled ocular hypertension or glaucoma
- History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis
- Trichiasis
- Corneal neuropathy
- Lagophthalmos or incomplete blink
- Any active or history of uveitis
- Active or history of keratitis, scleritis, endophthalmitis, or chronic blepharitis
- Suspected or active ocular or periocular infectious conjunctivitis or endophthalmitis
- Active or history of floppy eyelid syndrome
- Uncontrolled blood pressure
- Active or history of autoimmune diseases
- History of stroke within the last 3 months prior to informed consent
- Atrial fibrillation diagnosed or worsened within the last 3 months prior to informed consent
- History of myocardial infarction (MI) within the last 3 months prior to informed consent
- Confirmed active systemic infection
- History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that...
- Use of any systemic anti-VEGF agents
- Chronic use of oral corticosteroids
- Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer
The study team makes the final eligibility decision.
Where it is enrolling
- Innsbruck, Austria
- Linz, Austria
- Mistelbach, Austria
- Mladá Boleslav, Czechia
- Ostrava, Czechia
- Prague, Czechia
- Aarhus N, Denmark
- Glostrup Municipality, Denmark
- Nantes, Paris, France
- Lyon, France
- Montauban, France
- Paris, France
- Poitiers, France
- Strasbourg, France
- Chemnitz, Germany
- Düsseldorf, Germany
- Göttingen, Germany
- Hanover, Germany
- Rostock, Germany
- Würzburg, Germany
+ 35 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Innsbruck, Austria; Linz, Austria; Mistelbach, Austria; Mladá Boleslav, Czechia; Ostrava, Czechia; Prague, Czechia and 49 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.